跳至主要内容
临床试验/NCT03678337
NCT03678337Unknown不适用

Prevention and Pharmacological Management of Cardiac Adverse Drug Reactions Induced by Drugs Used in Oncology. The PICARO Cohort

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年2月26日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Number of Participants With AntiCancer Drugs-Related Cardiac Adverse Events during the follow-up

研究概览

简要总结

Recently, the medical management of cancer patients has considerably improved the prognosis of these patients and today some cancers are becoming "chronic diseases". As a result, new adverse effects (AEs) are observed, particularly cardiac.

These "new" cardiac AEs are the consequence of a significant increase in patients life expectancy (delayed AEs not previously seen) but also the use of new pharmacological classes of anticancer drugs such as kinase inhibitors. The incidence of these cardiac AEs varies according to the patient profile and the anticancer molecules used, but their impact on the morbidity and mortality of the patients is significant.

In this context, we started at the University Hospital of Caen Normandy in September 2017 a cardio-oncology program entitled "prevention and pharmacological management of cardiac adverse effects induced by drugs used in Oncology" (PICARO program). This program involves the pharmacology department (opening of a dedicated consultation), the cardiology department (opening of a dedicated ultrasound consultation), vascular medicine departement (opening of a dedicated consultation) and the oncology federation. This program aims to be regional in the future. We therefore propose to build a cohort backed up to the PICARO program to assess the regional impact of cardiac AEs of anticancer drugs and thus to be better able to specify the number of AEs, the incidence and regional prevalence of these drugs. .

The constitution of this cohort is only the first step towards the constitution in the near future (2 years) of an observatory and then a regional registry of cardiac AEs induced by anticancer drugs. The objectives associated with the establishment of such a registry would be to reduce the number of cardiac AEs, the hospitalizations caused by these AEs, a better information of health professionals and patients, an improvement in the screening of patients at risk, all coming back in the context of health, clinical, epidemiological and pharmacological surveillance.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient ≥ 18 years,
  • Attents of cancer,
  • Addressed for the first time to one of the PICARO program consultations at the University Hospital of Caen Normandy,
  • Written informed consent,
  • Patient beneficiary of the french social insurance.

排除标准

  • Minor and major protected patients
  • pregnant or nursing women
  • patient already included in the PICARO cohort
  • Patients under guardianship, curatorship, safeguard of justice or legal protection.

结局指标

主要结局

Number of Participants With AntiCancer Drugs-Related Cardiac Adverse Events during the follow-up

时间窗: 2 years

次要结局

  • Plasmatic tests to predict anticancer drugs-related cardiac adverse events from the constitution of the plasma biobank(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验